[Federal Register Volume 71, Number 182 (Wednesday, September 20, 2006)]
[Notices]
[Pages 54999-55000]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-7983]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006D-0303]


Draft Guidance for Industry on Public Availability of Labeling 
Changes in ``Changes Being Effected'' Supplements; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Public 
Availability of Labeling Changes in `Changes Being Effected' 
Supplements.'' The guidance announces to holders of a new drug 
application (NDA), an abbreviated new drug application (ANDA), or a 
biologics license application (BLA), who intend to submit a ``Changes 
Being Effected'' supplement (CBE supplement) to make a postapproval 
labeling change, that FDA will make labeling revisions identified in a 
CBE supplement publicly available upon receipt of the supplement by 
FDA. The guidance does not have any bearing on supplements that relate 
to chemistry, manufacturing, and controls changes, nor does it expand 
the circumstances in which an ANDA holder may effect labeling changes 
via a CBE supplement.

DATES:  Submit written or electronic comments on the draft guidance by 
November 20, 2006. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 
Evaluation and Research, Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857. Send one self-addressed adhesive label to 
assist that office in processing your requests. Submit written comments 
on the draft guidance to the Division of Dockets Management (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Meredith S. Francis, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-2041.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Public Availability of Labeling Changes in `Changes Being 
Effected' Supplements.'' FDA has begun an initiative to facilitate 
computerized access to drug information by consumers, pharmacists, and 
health care providers so that they will have faster and more 
comprehensive access to drug information. As part of this initiative, 
the agency has been involved in the development of a computerized 
repository of a broad array of drug information, known as ``DailyMed.'' 
Among other things, DailyMed contains the information referred to as 
``content of labeling,'' which includes all the information found in 
prescription drug labeling and over-the-counter (OTC) drug facts 
labeling, including all text, tables, and figures (see 21 CFR 
314.50(l)(1)(i)). To maximize its ability to serve as a useful resource 
to consumers, pharmacists, and health care providers, DailyMed must 
contain the

[[Page 55000]]

most up-to-date and comprehensive drug information available.
    Sections 314.70 and 601.12 (21 CFR 314.70 and 601.12) of FDA 
regulations identify the types of supplemental applications that must 
be submitted to FDA to effect a labeling change to approved NDAs, 
ANDAs, and BLAs. Certain types of changes to labeling should receive 
FDA approval before the changes are implemented. These include all 
labeling changes that do not fall under Sec.  314.70(c)(6)(iii), 
(d)(2)(ix), or (d)(2)(x), or under Sec.  601.12(f)(2) or (f)(3). Other 
changes may be implemented by a sponsor upon the agency's receipt of a 
CBE supplement. These changes are identified in Sec. Sec.  
314.70(c)(6)(iii) and 601.12(f)(2)(i).
    In the past, FDA has not made labeling publicly available until it 
has been approved, either under a pre-approval supplement or under a 
CBE supplement. To make the most current labeling submitted to FDA 
available to health care practitioners and the public, and to 
facilitate the DailyMed initiative, FDA will make the revised labeling 
proposed in a CBE supplement publicly available on its Web site and 
through DailyMed shortly after the CBE supplement is received and 
before FDA has necessarily reviewed or approved it. If, after reviewing 
the CBE supplement, FDA decides it should not be approved, FDA will 
either: (1) Remove the labeling submitted with the CBE supplement from 
FDA's Web site and from DailyMed and replace that labeling with the 
previous labeling; or (2) recommend the sponsor amend its labeling and, 
after the sponsor submits the amended labeling, post the amended 
labeling on FDA's Web site and provide it to DailyMed promptly.
    A sponsor should not submit a CBE supplement to FDA until the 
sponsor is ready to distribute the labeling that it proposes in that 
CBE supplement. FDA will consider the submission of a CBE supplement to 
be consent by the sponsor to post the proposed labeling on FDA's Web 
site and on DailyMed.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on public 
availability of labeling changes in CBE supplements. It does not create 
or confer any rights for or on any person and does not operate to bind 
FDA or the public. An alternative approach may be used if such approach 
satisfies the requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on the draft guidance. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. The draft guidance and received 
comments may be seen in the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: September 13, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06-7983 Filed 9-19-06; 8:45 am]
BILLING CODE 4160-01-S